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Completed

NCT Number: NCT01451710

The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy

This is a single center,prospective,no-controlled clinical trial

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Macular dystrophy, corneal type 1 Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine

Nanjing, Jiangsu, China

About this study

  • The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
  • The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female or male patients aged between 18 to 65 years
  • Renal biopsy was used to diagnose IgA nephropathy
  • Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L

Exclusion criteria

  • Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
  • urine RBC > 1 million/ml
  • Patients who have received treatment of enough steroids for more than 12 weeks
  • patients with secondary IgA
  • Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
  • Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2

Treatment and study plan

Prednisone or Prednisolone

Drug

daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day

Other names: Prednisone, prednisolone, corticosteroids

Primary outcomes

  1. 24h urinary protein excretion

    Time frame: 3 months

Secondary outcomes

  1. remission rate

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 14, 2011
Registry last updated
Jul 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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